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On April 25, 2008, manufacturer Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) and distributors Mylan Pharmaceuticals and UDL Laboratories, Inc. announced a complete Class I recall of all Digitek (digoxin) tablets. The tablets were marked with either a "Bertek" label or a UDL label. The recall was due to the possibility that the tablets contained twice the active ingredient listed. Taking the double dosage could lead to low blood pressure, cardiac instability, and even death.
Digitek is a drug used to treat arrhythmias (abnormal heart rhythm) in patients and to prevent heart failure. When it was first approved for use, the FDA noted that it had a "narrow therapeutic range" and presented a "potential risk" to patients if not presented in tablets of consistent, predictable quality. The FDA even instituted special quality controls to ensure that the quality of all oral digoxin products be strictly controlled.
However, in 2006 and 2007, Digitek tablets were part of what were called Class III recalls due to mispackaging and misbranding. The FDA noted in one recall that "there is the possibility of multiple product packaging mix-ups. An OTC drug, Rx drug, or nutritional supplement other than what is indicated on the product labeling may be inside the packaging."
The FDA says that the recall was being performed "as precaution," but also notes that "several reports of illnesses and injuries have been received." There is concern that the mistaken doses of digoxin have been sold for as long as a year. Here are some of the signs to look for if you believe you may be suffering from digitalis toxicity:
If you take Digitek and have suffered from any of these symptoms, contact your physician immediately.
The attorneys at Jacoby & Meyers can help you receive compensation for your damages. We will review the facts surrounding your injury and advise you on the best way to proceed with your defective drug claim.
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